Kornimate/medical-research-clean huggingface dataset:
biomarker study of chemotherapy resistance and outcomes in samples from older patients with acute myeloid leukemia

Conditions: Leukemia

Summary: rationale: studying blood samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research trial studies biomarkers related to chemotherapy resistance and outcomes in samples from older patients with acute myeloid leukemia.

objectives: * delineate the spectrum of genetic and epigenetic lesions occurring in elderly patients with acute myeloid leukemia (aml). * determine the biological functions perturbed by these lesions. * identify and validate lesions or pathways that are most highly associated with chemo-sensitive and chemo-refractory disease, and with adverse outcome in elderly aml. * identify potential classifiers and biomarker lesions that we can then evaluate prospectively in the e2906 trial which is about to begin enrollment. outline: dna and rna extracted from cell samples are analyzed for genetic and epigenetic expression by agilent sureselect sequencing, illumina hiseq2000 platform coding and sequencing, dna methylation, and microarray assays. results are then associated with patients' overall survival, progression-free survival, and complete response rate. results are also analyzed assessing the prognostic relevance of known mutations and epigenetic alterations that have shown to have an impact on overall survival and response to therapy in younger patients with acute myeloid leukemia (aml) in e1900 including, but not limited to, flt3, dnmt3a, idh1, idh2, tet2, asxl1, wt1, and mll, and 15-gene dna methylation classifier, and with novel recurrent mutations identified by other aml-profiling efforts.

Eligibility criteria:
disease characteristics: * subset of patients diagnosed with acute myeloid leukemia (aml) enrolled on e3999 * aml resistant or sensitive to chemotherapy * mononuclear cell samples available patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adult acute myeloid leukemia with 11q23 (mll) abnormalities adult acute myeloid leukemia with del(5q) adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) untreated adult acute myeloid leukemia adult acute myeloblastic leukemia without maturation (m1) adult acute myeloblastic leukemia with maturation (m2) adult acute myelomonocytic leukemia (m4) adult acute monoblastic leukemia (m5a) adult acute monocytic leukemia (m5b) adult erythroleukemia (m6a) adult pure erythroid leukemia (m6b) adult acute megakaryoblastic leukemia (m7) adult acute minimally differentiated myeloid leukemia (m0)
non-invasive repetitive paraorbital alternating current stimulation therapy for aphasia

Conditions: Aphasia

Summary: the investigators assess if repetitive, transcranial alternating current stimulation (rtacs) can improve the speaking quality of the aphasic patient as well as other communication skills as naming, repeating and understanding spoken words, reading and writing. further, it will be assessed if memory and attentiveness deficiencies after 10 days of therapy with brain stimulation are stabilized and remain stable after a training-free period of 60 days.


Eligibility criteria:
inclusion criteria: * stroke * lesion age at least 6 months * aphasia with at least moderate severity according to aachener aphasia test (aat) * age between 40 and 75 * german-speaking (at a native speaking level) exclusion criteria: * cognitive or speech-language therapy during the 2-weeks stimulation course * intensive language training when exceeding 1 hour, 2 times a week during the 2-weeks stimulation course and the follow-up period (60 days after stimulation was completed) * additional neurological diseases, e.g. surgical brain tumor removal, untreated tumor disease, acute traumatic brain injury, and/or craniotomy * (severe) dysarthria * untreated hypertension exceeding 160/100 mmhg (patients with treated hypertension and blood pressure below 160/100 mmhg can be included) * increased risk of vascular thrombosis * epilepsy, photo sensitivity, acute focal findings (patients without focal findings or epileptiform discharges can be included when they had only a single seizure more than 10 years ago) * dementias and neurodegenerative diseases * significant psychiatric disturbances, e.g. schizophrenia * major attention and/or memory deficits * major hearing loss * patients with uncorrected visual deficits * severe global aphasia * modality-specific disorders (pure speech apraxia, pure alexia, pure agraphia) * electric or electronic implants (e.g. heart pacemakers) * metal artefacts located at the head * medication with impact on the central nervous system (e.g. antidepressant or sedative drugs) * participation in another trial * pregnant or breastfeeding women

Keywords: stroke aphasia language
nppv added inspiratory muscle training in severe copd

Conditions: Chronic Obstructive Pulmonary Disease; Hypercapnic Respiratory Failure

Summary: the aim of this study is to determine whether noninvasive positive pressure ventilation with inspiratory muscle training can improve quality of life and respiratory muscle strength than noninvasive positive pressure ventilation or inspiratory muscle training alone.


Eligibility criteria:
inclusion criteria: 1. aged 40-75 years, male or female. 2. have spirometric evidence of copd with an fev1 of \< 50% predicted and fev1/fvc \< 0.70, measured within the last 6 months (gold stage iii and iv). stable disease since 4 weeks or more prior to randomisation. 3. pco2 of 7 kpa, combined with a ph of 7.35 or above. these gases must be measured after 30 minutes breathing room air in sitting position 4. no treatment with nppv and respiratory muscle training in the last 8 weeks exclusion criteria: 1. smokers can be excluded; 2. diseases of the lung or thorax besides copd: osa advanced pulmonary fibrosis, advanced bronchiectases, active tuberculosis, post tuberculosis syndrome, pneumonia, severe kyphoscoliosis, tracheostoma, neuromuscular diseases, or any other disorder, which might result in elevated pco2 3. body mass index of 35 kg/m² or above. severe cardiac disease, nyha iv, instable angina, severe cardiac arrhythmia, especially of ventricular origin (atrial fibrillation is not an exclusion criterion). 4. local derangement of the face, skin, tongue, upper airways, larynx and upper oesophagus. 5. severe chronic diseases except copd, hindering the patient to follow the schedule of this study

Keywords: copd noninvasive positive pressure ventilation respiratory muscle training
acupuncture for management of balance impairment in patients with parkinson's disease

Conditions: Parkinson Disease; Acupuncture

Summary: this plan is to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for pd patients. this is a randomized, controlled, single-blind clinical trial.

background: parkinson's disease (pd) is an age-related progressive neurodegenerative disease. the etiology and pathogenetic mechanisms that cause pd are still not fully understood. scalp acupuncture (sa), a common treatment modality within complementary and alternative medicine, has been widely used for pd. objective: to evaluate the effectiveness of scalp acupuncture, a modern acupuncture technique specialized to neurological disorders, in managing motor function and body balance for pd patients. design: randomized, controlled, single-blind clinical trial. setting: department of neurology, chang bing show chwan memorial hospital in changhua county. participants: patients with pd of grade 1 to 3 of hoehn \& yahr (h\&y) scale (n = 26). interventions: sa group (si shen cong and baihui) or control group. the techniques were administered by traditional chinese medicine trained in sa and evaluated at baseline and at 20 and 30 minutes. main outcome measure: motor score subscale of unified parkinson's disease rating scale (updrs) was used to measure the motor performances. balance ability in each patient was assessed as follows: subjects were placed on a force platform (sps, synapsys posturography system) to assess the displacement area from the centre of gravity, either with eyes open or closed, in a standing posture. the mini balance evaluation systems test (the mini-bestest) was used to measure the performance of balance and walking speed. the test was repeated twice each in baseline period, sa period and post-sa period. the mann-whitney u test, chi-square test, and fisher's exact test were used to compare the baseline characteristics of the 2 groups. one-way repeated measures anova was used to examine the differences among different time points (before, during, and after acupuncture treatment) within a group. association between continuous variables was evaluated with spearman's rank correlation coefficient.

Eligibility criteria:
inclusion criteria: * age 50-75 * meet the diagnostic criteria of parkinson's disease: uk (united kingdom) parkinson's disease society brain bank clinical diagnostic criteria * disease severity of hoehn-yahr stage: stage i to iii * clinical condition stable, not adjusting medicine in recent 3 months * no falling episode in recent 1 year * live independently exclusion criteria: * already enrolled in another studies * can't cooperate this evaluation examinations due to poor visual acuity, impaired cognitive function, musculoskeletal system disorder, or psychiatric illness * any other condition would make participants not to cooperative this study * can't tolerate acupuncture procedure

Keywords: scalp acupuncture parkinson's disease balance
a study of shr-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer

Conditions: Hepatocellular Cancer

Summary: the study was designed to evaluate the efficacy and safety of shr-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.


Eligibility criteria:
inclusion criteria: 1.18-75 years old, male or female. 2.hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery; 3.failure of at least one line of standard treatment (progression or intolerance); 4.according to the response evaluation criteria in solid tumors (recist v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion); 5.expected survival time ≥ 12 weeks; 6.normal function of major organs; 7.the subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up. exclusion criteria: 1. known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type); 2. evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenahave central nervous system metastasis;l syndrome, sepsis, etc.; 3. have central nervous system metastasis; 4. have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation); 5. have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study; 6. other situations in which the investigator deems that the subject should not be included.

Keywords: hepatocellular cancer
transcutaneous electrical nerve stimulation for pain mitigation during intrauterine device placement

Conditions: Pain

Summary: investigators are conducting a study to determine whether high frequency transcutaneous electrical nerve stimulation (hftens) is effective at reducing pain in women having an iud inserted.

the intrauterine device (iud) is a highly effective contraceptive method with increasing utilization in the last decade. the procedure to both place and remove an iud is typically performed in the ambulatory gynecologic clinic. pain associated with iud insertion is variably described, and evidence suggests that physicians underestimate the severity of pain patients experience with this procedure. studies have quantified the experience of pain using visual analog scales, demonstrating moderate insertional pain ranging from 5 to 7 out of 10 cm (equivalent to 50-70 out of 100 mm) on vas. increasingly, both academic and lay media reports highlight that traumatic nature of a painful iud placement and call providers to acknowledge and address the pain of iud placement in a meaningful way. to date, research has not identified a highly effective strategy to reduce pain during iud placement. transcutaneous electrical nerve stimulation (tens) is a low-cost, low-risk, nonpharmacologic intervention for pain management. the handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction. high frequency tens (\>50 hz; "hftens") significantly reduces pain associated with dysmenorrhea and a range of outpatient gynecologic procedures, including medication abortion, hysteroscopy, and uterine aspiration. this study evaluates an intervention to address pain during iud placement in the ambulatory setting.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form for iud insertion * stated willingness to comply with all study procedures * english speaking individuals aged 18 years or older * presenting for iud initiation during ambulatory care visit at musc women's health * opting for either lng 52mg or copper t380a iud exclusion criteria: * contraindication to iud initiation (i.e. pregnancy, current pelvic infection, distorted uterine anatomy) * contraindication or allergy to ibuprofen * history of a chronic pain disorder * recent opioid use in the previous 30 days * history of a cardiac arrhythmia * history of heart disease (i.e. atrial fibrillation, congestive heart failure) * presence of an implantable device with an electrical discharge (i.e. pacemaker) * bmi \> 50 (class iv obesity) * history of tens use * planned pain intervention outside standard of care (i.e. paracervical block, misoprotol) or preprocedure use of non-standard pain medication (i.e. benzodiazepines, marijuana, muscle relaxers, gabapentin, benadryl) * history of epilepsy

Keywords: obstetrics and gynecology
safety and efficacy study of a0001 in patients with the a3243g mitochondrial dna point mutation

Conditions: Neuromuscular Disease

Summary: this is a phase 2a, double-blind, placebo-controlled, single-center study. twenty-one patients who qualify for the study will be randomly assigned to either active drug or placebo. the study will take place at newcastle university. patients will have a 66% chance of getting active drug. patients will be required to take study treatment orally twice a day for 28 days. a baseline visit will occur within 21 days of screening visit. all patients will be followed for 1 week after completion of study or early withdrawal from the study.


Eligibility criteria:
inclusion criteria: * diagnosis of neuromuscular symptoms due to the a3243g mitochondrial dna point mutation * pcr/atp ratio of \<1.9 following the cardiac mrs at screening exclusion criteria: * any major illness not due to the a3243g mitochondrial dna point mutation in the past three months or any significant ongoing chronic medical illness, especially significant central nervous neurological disease limiting capacity to carry out the study * use of any investigational product within the past 30 days

Keywords: a3243g mitochondrial dna point mutation
university of california, san diego (ucsd) suramin autism treatment-1 (sat1) trial

Conditions: Autism Spectrum Disorders

Summary: this study is designed to test the safety and efficacy of a single, intravenous dose of suramin in autism spectrum disorders (asd).

this study is designed to test a new theory of the origin and treatment of asd. in this theory, asd is caused by both genes and environment interacting to produce a persistent cell danger response (cdr; naviaux rk, 2014) that interferes with and alters normal child brain development. gut microbiome and immune systems are also affected. in this theory, the pathological persistence of the cell danger response is traceable to mitochondria, and maintained by purinergic signaling mediated by the release of extracellular nucleotides like adenosine triphosphate (atp), adenosine diphosphate (adp), uridine triphosphate (utp), and uridine diphosphate (udp). suramin inhibits excess purinergic signaling by acting as a competitive inhibitor of nucleotide signaling at both ionotropic purinergic (p2x) receptors, and g-protein coupled, metabotropic purinergic (p2y) receptors. suramin has been found to correct the symptoms, metabolism, and brain synaptic abnormalities in two classical genetic and environmental mouse models of autism (naviaux jc, et al. 2015; naviaux jc, et al. 2014; naviaux rk, et al. 2013). this study will test the safety and efficacy of a single dose of suramin in children with asd. while it is not anticipated that a single dose will produce benefits for more than a few weeks, if successful, this study may lead to the development of newer and safer drugs for autism treatment.

Eligibility criteria:
inclusion criteria: * autism diagnostic observation schedule (ados) score of ≥ 7 * diagnosis of autism spectrum disorder by diagnostic and statistical manual, 5th edition (dsm-v) * stable treatment and diet regimen for ≥ 2 months * resident of san diego region exclusion criteria: * any prescription medications * hospitalization within the previous 2 months * active medical problem such as seizures, heart, liver, kidney, or adrenal disease * planning to start a new drug, diet, or behavioral intervention during the study * weight under the 5th percentile for age * unable to tolerate venipuncture, urine collection, or an indwelling intravenous catheter for 3-4 hours * plasma creatinine ≥ 1.4 mg/dl * liver function alanine amino transferase (alt) or aspartate amino transferase (ast) ≥ 1.5-fold above the upper limit of normal * known intolerance to suramin or other antipurinergic drugs * unable to perform or cooperate with study requirements

Keywords: mitochondria purinergic signaling cell danger response
neoadjuvant combined endocrine and her2 target therapy in postmenopausal women with er and her2 positive breast cancer

Conditions: Breast Cancer

Summary: cross-talk between epidermal growth factors and the er occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.combined her1/her2-targeted therapy with aromatase inhibitors for er-positive and her-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.

1. to evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with er-positive and her2-positive breast cancer. 2. to assess markers predictive of treatment response and outcome in this setting.

Eligibility criteria:
inclusion criteria: * written informed consent * female patients * histologically confirmed invasive breast cancer * primary tumor greater than 2cm diameter, measured by sonography * n0-3 (any n if resectable) and no evidence of distant metastasis (m) (isolated supraclavicular node involvement allowed) * er positive (intermediate and strong positive) * her2 positive (ihc3+ or fish positive in case of ihc 2+) * no evidence of metastasis (m0) * no prior hormonal, chemotherapy or radiotherapy is allowed * no breast operation other than biopsy to make diagnosis is allowed * postmenopausal women with ecog performance status of 0 or 1 * postmenopausal, as defined by any of the following: * at least 55 years of age * under 55 years of age and amenorrheic for at least 12 months or follicle-stimulating hormone (fsh) values ≥ 30 iu/l and estradiol levels ≤ 20 iu/l * prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months * adequate hematopoietic, renal, hepatic function: exclusion criteria: * patients who received hormonal, chemotherapy or radiotherapy for breast cancer * patients who underwent surgery for breast cancer * patients with bilateral invasive breast cancer * patients with inflammatory breast cancer (t4d) * patients without primary tumor (t0) inability to perform \[18f\]fes pet imaging due to physical inability, claustrophobia, or other mental illness. * er poor disease as defined locally (e.g: allred score 1-3, h-score\<100) * patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer * chronic daily treatment with aspirin (\>325mg/day) or clopidogrel (\>75mg/day) * chronic daily treatment with corticosteroids (dose of \>10mg /day ethylprednisolone equivalent) * clinically significant cardiovascular disease: cva/stroke (\<6month prior to enroll), mi (\<6month prior to enroll), unstable angina, nyha grade ii or greater congestive heart failure, or serious cardiac arrhythmia requiring medication. * hormone replacement therapy within 4 weeks of starting treatment * known hypersensitivity to any of the study drugs including ditosylate monohydrate salt * pregnant or nursing mother (if applicable)

Keywords: neoadjuvant letrozole lapatinib postmenopausal
phenotypic and genetic factors in autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: the purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with autism spectrum disorders (asds) and their families.

participation in this research study involves two research visits, at least one of which is at children's hospital boston. the first visit lasts about 4-6 hours. on this visit, the child will work with a research assistant on a few different cognitive assessments while one or both parents answer interview questionnaires about the child's development, along with other family history information. the second visit at the hospital lasts about 2 and a half hours and involves medical history and family history questionnaires, as well as height, weight, and head circumference measurements and a blood draw from each family member. in addition, digital photographs will be taken of each family member and a 3-d picture of the child's face will be taken. shortly after the visits, participants will receive a research report of our observations. these results include cognitive, behavioral, developmental, and social findings. the total time commitment for the study is 6 to 8 hours.

Eligibility criteria:
inclusion criteria: * diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray) * age ≥ 18 months exclusion criteria: * presence of a metabolic disorder * acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy

Keywords: autism spectrum disorder autism asperger syndrome pervasive developmental disorders- not otherwise specified